SneakPeek Gender Test Lawsuit: Allegations, Outcome, and Refunds

The SneakPeek gender test lawsuit was a 2015 class action filed in federal court in California accusing Gateway Genomics of falsely marketing its at-home SneakPeek Early Gender DNA Test as 99% accurate when, the plaintiffs said, real-world results were much less reliable. The case, Main et al v. Gateway Genomics, LLC dba SneakPeek, was dismissed on July 27, 2017, and no public settlement or ruling on the merits has surfaced.1Top Class Actions. SneakPeek Class Action Challenges Accuracy of Early Gender Test

What the Plaintiffs Alleged

The complaint, filed in December 2015 in the U.S. District Court for the Southern District of California, argued that Gateway Genomics had sold customers a “false bill of goods.” Named plaintiff Kristine Main alleged the test’s actual accuracy was “much closer to a flip of a coin” than the advertised 99%, pointing to consumer complaints and online forum discussions suggesting correct results only about 60% of the time.2Truth in Advertising. SneakPeek Early Gender Test1Top Class Actions. SneakPeek Class Action Challenges Accuracy of Early Gender Test

Attorneys for the plaintiffs said the inaccurate results caused “emotional torture” and “gender disappointment” for parents who had bought clothing, chosen names, and told family based on what they were told.3News 5 Cleveland. Women Suing Company Over Wrong Sex Test Results

The suit brought claims under California’s Unfair Competition Law and False Advertising Law, along with fraud, breach of express warranty, and unjust enrichment.1Top Class Actions. SneakPeek Class Action Challenges Accuracy of Early Gender Test The company’s disclaimer at the time said the test “detected shared male fetal DNA in >99% of pregnant women carrying male fetuses at 9 weeks gestational age and later into pregnancy.” The plaintiffs argued that language did not reflect what customers actually experienced with at-home collection.4ABC 10News San Diego. Lawsuit: Gender Tests False, Don’t Deliver

The Named Plaintiff’s Experience

Kristine Main, an Ohio woman, took the SneakPeek test at 14 weeks pregnant in February 2015, paying $169. On February 9, 2015, an emailed result predicted a girl. She picked a name, bought clothing, and told friends and family. A later ultrasound showed she was carrying a boy, and she gave birth to a son, Brayden, in July 2015.3News 5 Cleveland. Women Suing Company Over Wrong Sex Test Results4ABC 10News San Diego. Lawsuit: Gender Tests False, Don’t Deliver

Main said she felt she had “lost” the daughter she had been preparing for. Her attorneys said the case was filed on behalf of hundreds of other women who reported similarly incorrect results.4ABC 10News San Diego. Lawsuit: Gender Tests False, Don’t Deliver

How the Case Ended

Gateway Genomics did not address the specific allegations publicly. Asked for comment, the company said only: “The company stands behind its product. It is our company policy to not discuss pending litigation.”3News 5 Cleveland. Women Suing Company Over Wrong Sex Test Results

The court dismissed the lawsuit on July 27, 2017. The available record does not detail the grounds for dismissal, and no published settlement or decision on the merits has surfaced.1Top Class Actions. SneakPeek Class Action Challenges Accuracy of Early Gender Test

Why the Test Can Get It Wrong

SneakPeek is a non-invasive prenatal test that looks for cell-free fetal DNA in the pregnant person’s blood. If Y-chromosome DNA turns up in the sample, the result predicts a boy; if none is detected, it predicts a girl.5SneakPeek. How It Works

That design has a built-in vulnerability. Because the test scans for male DNA, any contamination from an outside male source can produce a false “boy” result. SneakPeek’s own materials tell users to wash their hands, clean the collection area, and keep anyone with Y chromosomes away from the sample. Other listed sources of error include testing too early, irregular menstrual cycles that lead to a miscalculated gestational age, a “vanishing twin,” or residual fetal DNA from a prior pregnancy.6SneakPeek. Can a Gender Blood Test Be Wrong

Why the FDA Doesn’t Police These Claims

The SneakPeek test is a laboratory-developed test, or LDT. The FDA does not review or approve LDTs before they reach the market. According to the Pew Charitable Trusts, more than 40 noninvasive prenatal tests were on sale as of 2021, and none had been cleared or approved by the FDA.7The Pew Charitable Trusts. Diagnostic Tests Not Reviewed by FDA Present Growing Risks to Patients

The Centers for Medicare and Medicaid Services regulate the labs that make these tests under the Clinical Laboratory Improvement Amendments of 1988, but that oversight is aimed at lab quality and personnel, not at whether a test actually delivers accurate results.8National Human Genome Research Institute. Regulation of Genetic Tests Companies are not required to report inaccurate results to the FDA, and the FDA cannot recall a faulty LDT.7The Pew Charitable Trusts. Diagnostic Tests Not Reviewed by FDA Present Growing Risks to Patients

The Federal Trade Commission can pursue misleading marketing claims under Section 5 of the FTC Act, but it does not evaluate the scientific validity of the tests themselves.8National Human Genome Research Institute. Regulation of Genetic Tests For a consumer who believes they were misled, the practical route is private litigation under state consumer protection and false advertising statutes. That is the route the SneakPeek plaintiffs took.

Refunds and Current Ownership

SneakPeek now offers what it calls a 100% refund guarantee for customers who receive an inaccurate gender prediction. To qualify, the baby has to be born and the biological sex must not match the test result. Customers submit a photo of a state-certified birth certificate, their order number, and other documentation through the company’s website.9SneakPeek. Incorrect SneakPeek At-Home Early Gender Test Results

Gateway Genomics was founded in 2014 and is based in San Diego.10Inside Precision Medicine. Myriad Acquires Gateway Genomics for $67.5M In November 2022, Myriad Genetics acquired the company for $67.5 million in cash, with up to $32.5 million in additional performance-based payments. Gateway had sold more than 750,000 tests by that point. The SneakPeek product moved into Myriad’s Women’s Health division and has continued under its original brand.11Myriad Genetics. Myriad Genetics Acquires Gateway Genomics

Other Prenatal Testing Lawsuits

The SneakPeek case was not alone in its industry. A class action against Natera, Inc. over its Panorama noninvasive prenatal screening test raised similar allegations about misrepresented reliability, particularly around false positives for rare genetic conditions.12Courthouse News Service. Class Action Over Prenatal Tests With False Positives Gets Trimmed by Court That case settled for $8.25 million, and Natera agreed to add disclosures stating that prenatal tests cannot determine fetal genetic conditions with certainty. Reporting on the Natera settlement noted similar accuracy-related allegations against Labcorp’s MaterniT21 and Myriad Genetics’ Prequel prenatal screening products.13ClassAction.org. $8.25M Natera Settlement Ends Class Action Lawsuit Over Allegedly Inaccurate Prenatal Testing